Custom Analytical Methods, Testing, & Verification
We recognize that every scientific endeavor is unique, which is why we take pride in offering tailor-made analytical solutions that align with your project’s unique objectives. Our commitment to precision and innovation sets us apart as your choice laboratory for custom analytical testing. Our seasoned team of analytical experts advance the development and validation of your custom analytical methods suited to your product’s unique needs.
While compendial testing according to pharmacopeial standards is common practice, we understand that your product might be a novel material and lack an established monograph. Whatever your circumstance, we have the capabilities and expertise to develop methodology that meets your needs for any compound or formulation.
Analytical Method Development & Validation Process
We ensure a seamless transition from your lab to ours, or vice versa, by assessing your method's requirements, instrument compatibility, and sample preparation procedures. Our team takes a step-by-step approach, carefully documenting and verifying each stage of the transfer. This process includes instrument calibration, method validation, and ongoing performance monitoring to guarantee your analytical methods continue to generate consistent and reliable results no matter which lab they are performed in.
Our development approach involves close collaboration with your team to define the specific objectives and analytical requirements of your project. We leverage our extensive experience and diverse expertise to design and create analytical methods tailored precisely to your unique needs. Our development process is characterized by iterative experimentation, method optimization, and rigorous validation to ensure the method's accuracy, precision, and suitability for your analytical goals.
We fine-tune existing analytical methods to enhance their performance and efficiency. We start by evaluating your current method and identifying areas for improvement. Our team then employs advanced techniques and state-of-the-art equipment to optimize critical parameters, such as sample preparation, chromatographic conditions, and detection. Through systematic adjustments and experimentation, we maximize the method's robustness, sensitivity, and cost-effectiveness, ultimately providing you with an improved and more reliable analytical approach.
Our validation approach encompasses a thorough assessment of method suitability, accuracy, precision, specificity, and robustness. Our experts affirm the reliability and accuracy of analytical methods to ensure they adhere to regulatory guidelines. We guide you through the entire validation process, verifying your methods meet the highest quality standards. We also meticulously document all validation activities, generate comprehensive reports, and provide the necessary support to help you meet regulatory requirements and confidently submit your data for approval.
USP <1225> Compliance and Industry Standards
Integrated Laboratory Services
Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.
Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.
Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.
Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.